Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

Inclusion Criteria:

1. Subject has ESRD and undergoes chronic HD at least two times per week

2. Subject has a HD catheter that has demonstrated the ability to achieve a minimumblood flow of at least 250 mL/min for at least two consecutive dialysis sessionsblood flow to enable successful HD

3. The HD catheter is implanted with the tip in a jugular or subclavian vein

4. The subject is not expected to expire within 180 days

5. The subject is likely to require the use of a CVC for at least 90 days

6. The subject (or the legal guardian) understands the nature of the study and provideswritten informed consent prior to the study enrollment

7. The subject is willing to comply with specified follow-up evaluations and prescribeddialysis therapy and

8. If female and of childbearing potential, the subject must have a negative pregnancytest at the screening visit (i.e., subject is not pregnant); not be lactating; anduse an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or hormonal contraceptive (oral, implant, ring,patch) for the duration of the study. (NOTE: The subject must have used the chosenmethod of birth control for at least 1 month/cycle prior to enrollment into thestudy).

Exclusion Criteria:

1. Subjects who received antibiotics within the last 14 days

2. Visible evidence of compromised skin integrity is present at the catheter exit siteor evidence of a catheter exit site infection

3. Subject has received any thrombolytic treatment (i.e., tPA) in their currentcatheter within 30 days of randomization

4. Fill volume of HD catheter is unknown or cannot be determined

5. Subjects using any type of antimicrobial-coated or heparin-coated catheter

6. Documented chronic bleeding diathesis, active or recurrent bleeding within 1 monthprior to randomization

7. Documented history of an atrial thrombus or known hypercoagulable state

8. Subjects with open, non-healing skin ulcers

9. Current requirement for systemic immunosuppression that would increase risk ofinfection

10. Active malignancy requiring or anticipated to require chemotherapy likely to causeleukopenia and/or immunosuppression

11. Known allergy or absolute contraindication to citrate, taurolidine or heparin or ahistory of heparin-induced thrombocytopenia

12. Unstable malignancy

13. Cirrhosis with encephalopathy

14. Subject is currently taking another medication with known systemic drug interactionwith citrate, taurolidine, or heparin

15. Subject is currently enrolled in another investigational device and/or drug trial orhas participated in another investigational device and/or drug trial within 30 daysprior to enrollment

16. Subject is anticipated to receive a renal transplant within 90 days (subjects can beon the transplant list, but a subject with a known or anticipated transplant datewithin the next 90 days should be excluded)

17. Any other medical condition which renders the subject unable to or unlikely tocomplete the study, or which would interfere with optimal participation in the studyor produce significant risk to the subject.